FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLADE SAFE
K Number: K810208
·
Decision Feb 12, 1981
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
112
Applicant Total
10
Review Days
17
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Basic Information
- Device Name
- BLADE SAFE
- K Number
- K810208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Instranetics, Inc.
- Date Received
- January 26, 1981
- Decision Date
- February 12, 1981
- Product Code
- MMK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MMK | Container, Sharps | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MMK), ordered by most recent decision date.
Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong
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Other Clearances by Instranetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823430 | INSTRA-SAFE | Jan 7, 1983 | Substantially Equivalent |
| K811824 | CAUTERY CADDY PAD | Jul 20, 1981 | Substantially Equivalent |
| K811823 | SHARPS CADDY FB | Jul 20, 1981 | Substantially Equivalent |
| K811822 | TIP-VU | Jul 20, 1981 | Substantially Equivalent |
| K810294 | LINE CADDY | Feb 26, 1981 | Substantially Equivalent |
| K802865 | SAFE T COUNT | Dec 18, 1980 | Substantially Equivalent |
| K802866 | SHARPS CADDY MAGNETIC & SHARPS CADDY FOA | Nov 17, 1980 | Substantially Equivalent |
| K781575 | DISPOSABLE LYMPHANGIOGRAM SET | Dec 4, 1978 | Substantially Equivalent |
| K770894 | NEURO-SORB PATTIES | Jun 20, 1977 | Substantially Equivalent |